FDA 483 - Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center - January 09, 2026

An FDA inspection of Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center in Irvine, CA, identified two observations. The firm failed to adequately screen oocyte donors for communicable disease risk factors and did not properly label Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from donors with incomplete screening. These issues indicate deficiencies in donor eligibility determination and product control.